This part specifies the classification, marking, material, physical, chemical, biological, marking and packaging requirements for medicinal liquid filter materials with a nominal pore size of 0.22 μm ~ 20 μm for medical infusion and injection equipment. The filter materials specified in this section include filter membrane materials and filter mesh materials. It is mainly used to filter out insoluble particles above the nominal pore size of the filter material in the medicinal liquid.
YY 0770.1-2009 Referenced Document
GB 6682 Analytical laboratory water specifications and test methods
GB 8368 Infusion sets for single use—Gravity feed*， 2018-03-15 Update
GB/T 14233.1 Test methods for infusion, transfusion, injection equipments for medical use—Part 1: Chemical analysis methods*， 2022-10-14 Update
GB/T 14233.2 Test methods for infusion,transfusion,injection equipment for medical use.Part 2:Biological test methods
GB/T 16886.1 Biological evaluation of medical devices—Part 1: Evaluation and testing within a risk management process*， 2022-04-15 Update
YY 0286.1-2007 Special infusion sets.Part 1:Infusion sets with precision filteers for single use